NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]

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NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]
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NDC 41250-031-02, 41250-473-40, 41250-668-40
Set ID d9bf2076-4d3f-4118-ab38-54ab61631716
Category HUMAN OTC DRUG LABEL
Packager Meijer Distribution Inc
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • Nighttime CoughActive ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves cold symptoms:

    •
    cough due to minor throat and bronchial irritation
    •
    runny nose and sneezing
  • Warnings

    Do not use

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    •
    glaucoma
    •
    cough that occurs with too much phlegm (mucus)
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    •
    excitability may occur, especially in children
    •
    may cause marked drowsiness
    •
    avoid alcoholic drinks
    •
    be careful when driving a motor vehicle or operating machinery
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    •
    take only as directed
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 30 mL contains: sodium 32 mg
    •
    store at 20-25°C (68°-77°F)
  • Inactive ingredients

    alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    1-800-719-9260

  • Daytime CoughActive ingredient (in each 15 mL)

    Dextromethorphan HBr 15 mg

  • Purpose

    Cough suppressant

  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

  • Warnings

  • Do not use

    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Ask a doctor before use if you have

    •
    cough that occurs with too much phlegm (mucus)
    •
    persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • Stop use and ask a doctor if

    cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    •
    take only as directed
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6-8 hrs

    children 6 to under 12 yrs

    15 mL every 6-8 hrs

    children 4 to under 6 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 15 mL contains: sodium 13 mg
    •
    store at 20-25°C (68-77F)
    •
    does not meet USP requirements for light resistant packaging
  • Inactive ingredients

    anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel – NiteTime Cough

    COMBO PACK

    Compare to Vicks® NyQuil® Cough active ingredients

    nitetime cough

    Dextromethorphan HBr

    Cough Suppressant

    Doxylamine Succinate | Antihistamine

    All Night Cough Relief

    Cherry Flavor

    ALCOHOL 10%

    Relieves: Cough, Sneezing, Runny Nose

    12 FL OZ (355 mL)

  • Principal Display Panel – DayTime Cough

    COMBO PACK

    Compare to Vicks® DayQuil® Cough active ingredient

    NON-DROWSY

    daytime cough

    Dextromethorphan HBr

    Cough Suppressant

    All Day Cough Relief

    Citrus Blend Flavor

    Alcohol Free

    Antihistamine Free

    Powerful Cough Relief for up to 8 hours

    12 FL OZ (355 mL)

    031-6e-daytime-nitetime.jpg
  • INGREDIENTS AND APPEARANCE
    NITETIME COUGH DAYTIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-031
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-031-021 in 1 KIT; Type 0: Not a Combination Product02/13/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 355 mL
    Part 21 BOTTLE 355 mL
    Part 1 of 2
    NITETIME COUGH 
    dextromethorphan hydrobromide, doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:41250-668
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorRED (Dark Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-668-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/03/2003
    Part 2 of 2
    DAYTIME COUGH  NON DROWSY
    dextromethorphan hydrobromide solution
    Product Information
    Item Code (Source)NDC:41250-473
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorORANGE (light) Score    
    ShapeSize
    FlavorCITRUS (blend) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-473-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/15/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/13/2013
    Labeler - Meijer Distribution Inc (006959555)
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